SARS CoV 2 InfectionNCT05043623
Diagnosis of Respiratory Viruses in Children With Rhinoswab Junior
A study testing Rhinoswab Junior, Combined nose and throat swab and Saliva swab in people with SARS CoV 2 Infection and COVID-19, run by Murdoch Childrens Research Institute at 1 site in Australia.
Trial summary
A study to investigate Rhinoswab as an alternative method to combined throat and deep nasal (CTDN) swab for respiratory sample collection in children who present to the Royal Children's Hospital (RCH) for viral testing. Children and their parent/guardian will answer a short survey about their preferences. Read more about this study
- Who is it for?
- Ages 1 month to 18 yearsHealthy volunteers can take part
- Conditions the study is for
- SARS CoV 2 Infection, COVID-19
- What is being tested?
- Rhinoswab Junior, Combined nose and throat swab and Saliva swab
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 339 participants
- Where
- 1 siteAustralia
- Study dates
- 26 Aug 2021to 28 Aug 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 month to 18 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Symptomatic and requiring a COVID-19 test at RCH or confirmed/suspected COVID-19 at home.
- Aged between 1 month -18 years old.
- Parent/guardian present.
- Parents/self are able to provide consent.
Who cannot join
- < 1 month or >18 years old.
- Recent head or neck surgery
- Inability (e.g. non-English speaking and if no interpreter is available) or unwillingness to consent
Trial locations and contacts
1 site in 1 country.
About this study
A study to investigate Rhinoswab as an alternative method to combined throat and deep nasal (CTDN) swab for respiratory sample collection in children who present to the Royal Children's Hospital (RCH) for viral testing. Children and their parent/guardian will answer a short survey about their preferences. Laboratory staff will answer a short survey about handling the different samples.
Read the detailed description
The microbiological test of choice for detection of respiratory viruses is a reverse transcription polymerase chain reaction (RT-PCR). The test is reported as "detected" or "not-detected" to the clinician. The Ct-value is a microbiological analysis that represents the number of amplification cycles required for a target gene to exceed a threshold level, to determine a negative or positive result and is interpreted to detect respiratory viruses. The Ct-value is used to measure viral load.
SARS-CoV-2, the virus that causes COVID-19, is a respiratory virus of specific interest. SARS-CoV-2 is detected in the upper respiratory tract. National guidelines for diagnosing COVID-19 in Australia require a combined throat and deep nasal swab (CTDN). No other testing options are routinely recommended in Australia. However, research and international guidelines recommend nasal swabs alone for SARS-CoV-2 detection. The Center for Disease Control and Prevention (USA) currently recommend the use of an anterior nasal swab alone as a method for detection of SARS-CoV-2. A recent systematic review suggested nasal swabs are a clinically acceptable alternative specimen collection methods. In addition to satisfactory diagnostic performance, nasal swabs are potentially less invasive, and can be self-collected.
Research at the Melbourne Children's Campus has identified that the CTDN or nasopharyngeal swab, are uncomfortable and distressing for children. The fear of the test is a barrier for presentation to a health service for a SARS-CoV-2 test. Parental and child reluctance to undergo testing may impact the public health response, through under-identification of pediatric cases.
The Rhinoswab is a TGA (Therapeutic Goods Administration) approved anterior nasal swab for children and adults. The design of the Rhinoswab allows for standardisation of the site of biological sampling, as compared with CTDN swabs which are operator dependent. It is designed to be more comfortable and to collect nasal secretions for PCR testing. The Rhinoswab Junior is a smaller paediatric version that has novelty features which add interest and distraction. The child can use the swab themselves, allowing autonomy and control. The capture and elution efficiency of the Rhinoswab has been shown to be comparable, if not slightly superior, to the capture and elution efficiency to the commercially available Copan eSwab by VIDRL (Victorian Infectious Diseases Reference Laboratory) and GNOMIX analyses.
The RCH has completed over 30,000 tests in children throughout the COVID-19 Pandemic from March 2020 to June 2021 at the Respiratory Infection Clinic and Emergency Department. The RCH nurses and doctors are well placed to trial the Rhinoswab due to extensive experience in testing children, and have developed related clinical practice guidelines.
This trial aims to determine the following in children 5-18 years of age:
- To determine the sensitivity and specificity of the Rhinoswab compared to the standard CTDN swab, in detecting viruses on the respiratory panel
- To determine whether Rhinoswab is non-inferior to the standard CTDN swab by comparing Ct values
- To determine the sensitivity and specificity of the throat swab alone and deep nasal swab alone, compared with the CTDN, in detecting respiratory viruses
- To investigate the comfort and preference of the Rhinoswab compared to the CTDN swab.
- To investigate the laboratory handling of the Rhinoswab compared to the CTDN swab.
- To determine the sensitivity and specificity of the Rhinoswab compared to CTDN swab, and saliva, in detecting respiratory viruses including SARS-CoV-2.
In children 1 month to 5 years:
- To investigate sensitivity and specificity of Rapid Antigen Test (RAT) compared to CTDN swab and saliva test in detected SARS-CoV-2
- Conditions
- SARS CoV 2 Infection, COVID-19
- Being tested
- Rhinoswab Junior, Combined nose and throat swab, Saliva swab, Abbott Panbio™ COVID-19 antigen self-test kit
- Keywords
- Rhinoswab Junior
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Rhinoswab JuniorDevice
Rhinoswab Junior is a single use self-administered nasal swab intended to collect clinical specimens from the patient's nasal passages
Combined nose and throat swabDevice
Combined nose and throat swab (standard of care)
Saliva swabDevice
Saliva swab
Abbott Panbio™ COVID-19 antigen self-test kitDiagnostic test
COVID-19 antigen self-test kit for the screening of active COVID-19 infection. It is a single-use, in vitro, visually read rapid immunoassay that uses a human nasal swab specimen for the qualitative detection of nucleocapsid protein SARS-CoV-2 antigen. It is intended to be used manually by untrained lay users (self testing) in a private setting.
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 - Clinician Collected/supervised Rhinoswab first, then CTDN swab | Experimental | Rhinoswab test administered and immediately followed by CTDN. Rhinoswab swab tested on respiratory panel vs CTDN swab tested on respiratory panel (standard of care). Receives: Device: Rhinoswab Junior; Device: Combined nose and throat swab |
| Arm 2 - Clinician Collected/supervised CTDN swab first, then Rhinoswab | Experimental | CTDN test administered and immediately followed by Rhinoswab. CTDN swab tested on respiratory panel (standard of care) vs Rhinoswab swab tested on respiratory panel. Receives: Device: Rhinoswab Junior; Device: Combined nose and throat swab |
| Arm 3 - Self-collected Rhinoswab, saliva swab, CTDN | Experimental | In children 5-18 years, the child/parent/guardian collects the three samples, in order of patient/parent preference. All samples will be tested on the SARS-CoV-2 laboratory panel (Allplex™ SARS-CoV-2 Assay - Seegene Inc) Receives: Device: Rhinoswab Junior; Device: Combined nose and throat swab; Device: Saliva swab |
| Arm 4 - Self-collected RAT, saliva, CTDN | Experimental | In children 1 month -5 years, the child/parent/guardian collects the three samples, in order of patient/parent preference. Saliva and CTDN samples will be tested on the SARS-CoV-2 laboratory panel (Allplex™ SARS-CoV-2 Assay - Seegene Inc), RAT test kit will be Abbott PanBio Receives: Device: Combined nose and throat swab; Device: Saliva swab; Diagnostic Test: Abbott Panbio™ COVID-19 antigen self-test kit |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sensitivity of Rhinoswab compared with CTDN for 13 viruses on standard respiratory panel (Clinician collected/supervised)
The results (detected/not detected) on all 13 viruses on the standard respiratory panel from both the Rhinoswab and the standard swabs will be obtained, and the sensitivity of the Rhinoswab compared to the CTDN determined. Sensitivity is calculated only in the participants who tested positive for the respective virus using the CTDN swab and is calculated as the proportion patients who tested positive on the Rhinoswab among those who tested positive on the CTDN swab. 95% confidence intervals will be calculated.
Measured: 5 minutes from administering test
Specificity of Rhinoswab compared with CTDN for 13 viruses on standard respiratory panel (Clinician collected/supervised)
The results (detected/not detected) on all 13 viruses on the standard respiratory panel from both the Rhinoswab and the standard swabs will be obtained, and the specificity of the Rhinoswab compared to the CTDN determined. Specificity is calculated only in participants who tested negative for respiratory viruses and is calculated as the proportion patients who tested negative on Rhinoswab among those who tested negative on CTDN swab. 95% confidence intervals will be calculated.
Measured: 5 minutes from administering test
Secondary outcomes (9)
Ct-Value of respiratory viruses on Rhinoswab compared with Ct-value of respiratory viruses on CTDN (Clinician-Collected/Supervised)
Median Ct-Value of respiratory viruses on Rhinoswab compared with Ct-value of respiratory viruses on CTDN for each detection will be compared. The CT value for the undetected sample will be set at the maximum number of cycles performed in the laboratory (CT value maximum of 38.73). If the upper limit of the confidence interval is more than 3 Ct-value, the two swabs will be regarded as non-inferior.
Measured: 5 minutes from administering test
Swab Preference Assessment (Clinician-Collected/Supervised )
The preferability for the Rhinoswab, compared to the standard sample for respiratory virus testing is determined, using the Likert scale or picture-based chart for standardised responses. Descriptive analyses will be used to describe child/parent/research preferences.
- Child/parent/research nurse will be asked to rate comfort for each swab: Extremely Comfortable 1 to Extremely Uncomfortable 5 B) What is your preference for future testing between CTDN and Rhinoswab? C) Which swab was better CTDN vs Rhinoswab?
Measured: 5 minutes from administering test
Median Ct-value of SARS-CoV-2 on Rhinoswab vs saliva vs CTDN (Self-collected)
Median Ct-Value of SARS-CoV-2 on Rhinoswab, saliva and CTDN will be compared. The CT value for the undetected sample will be set at the maximum number of cycles performed in the laboratory (CT value maximum of 38.73). If the upper limit of the 95% confidence interval for the median difference is less than 3 CT, the Rhinoswab will be regarded as non-inferior.
Measured: 5 minutes from administering test
Sensitivity of Rhinoswab compared with CTDN for SARS-CoV-2 (Self-collected)
Sensitivity is calculated only in the participants who tested positive for SARS-CoV-2 using the CTDN swab and is calculated as the proportion patients who tested positive on the Rhinoswab among those who tested positive on the CTDN swab.
Measured: 5 minutes from administering test
Specificity of Rhinoswab compared with CTDN for SARS-CoV-2 (Self-collected)
Specificity is calculated only in participants who tested negative for SARS-CoV-2and is calculated as the proportion patients who tested negative on Rhinoswab among those who tested negative on CTDN swab.
Measured: 5 minutes from administering test
Comparison of RAT test (detected/not detected) to Ct-values for saliva and standard CTDN for SARS-CoV-2 only (Self-collected)
The SARS-CoV-2 results (detected/not detected) from the RAT test will be compared with Ct-values from saliva and standard CTDN swabs.
Measured: 15 minutes from administering test
Sensitivity of RAT compared with saliva for SARS-CoV-2 only (Self-collected)
Sensitivity is calculated only in the participants who tested positive for SARS-CoV-2 using saliva and is calculated as the proportion patients who tested positive on RAT among those who tested positive on saliva.
Measured: 15 minutes from administering test
Sensitivity of RAT compared to standard CTDN for SARS-CoV-2 only (Self-collected)
Sensitivity is calculated only in the participants who tested positive for SARS-CoV-2 using the CTDN swab and is calculated as the proportion patients who tested positive on RAT among those who tested positive on CTDN swab.
Measured: 15 minutes from administering test
Laboratory handling assessment
At the end of the study, the laboratory staff will be asked:
- Rate the handling experience of Rhinoswab vs CTDN using a Likert scale:
Rhinoswab was easier to handle 1 to Rhinoswab was harder to handle 3 B) Was there a difference in processing the Rhinoswab versus the combined throat and deep nasal swab?: Rhinoswab was easier to process/There was no difference in processing/Rhinoswab was harder to process C) How did the Rhinoswab impact the workflow or lab efficiency compared to the standard combined throat and deep nasal swab?
1 Very easy and no impact on workflow or lab efficiency to 5 Very difficult and many complications on workflow or lab efficiency D) What benefits or challenges, did you observe when working with Rhinoswab in the lab? (Freetext)
Measured: 5 minutes for survey, to be completed up to 14 days post the last participant enrolled
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2021
- Study start26 Aug 2021
- Primary completion26 Jan 2022
- Study completion28 Aug 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for SARS CoV 2 InfectionStudies of the same condition, open and under way.
- More trials run by Murdoch Childrens Research InstituteThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- The study is organised sequentially into three phases due to research capacity Phase 1: The first 250 participants (5-18 years) will be randomly assigned to Arm 1 and Arm 2 for the clinician collected/supervised phase. Phase 2: 50 participants (5-18 years) will be allocated to Arm 3 for the self-collected Rhinoswab/saliva/combined nose+throat swab. Phase 3: 50 subsequent participants (1m - 5 years) will be allocated to Arm 4 for the self-collect throat+nose/saliva/RAT
- Masking
- None (open label)
- Enrolment
- 339 participants (actual)
Sponsor and investigators
- Lead sponsor
- Murdoch Childrens Research Institute
- Sponsor type
- University, hospital or other
- Collaborators
- Rhinomed Pty Ltd
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05043623
- Sponsor's protocol ID
- HREC/77305/RCHM-2021
- Status last verified
- Feb 2023
- First submitted
- 26 Aug 2021
- Last updated
- 8 Feb 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Beginning 12 months following analysis and article publication, the following will be made available long-term for use by future researchers from a recognised research institution whose proposed use of the data has been ethically reviewed and approved by an independent committee and who accept MCRI's conditions for access: • Individual participant data that underlie the results reported in this article after de-identification (text, tables, figures and appendices).
Publications
Tosif S, Lee LY, Nguyen J, Overmars I, Selman C, Grobler AC, McMinn A, Waller G, McNab S, Jarvis T, Steer A, Babl FE, Daley A, Crawford NW. A novel anterior nasal swab to detect respiratory viruses: a prospective study of diagnostic accuracy. BMC Pediatr. 2023 Apr 28;23(1):201. doi: 10.1186/s12887-023-03976-5.
PubMed 37106344Tosif S, Lee LY, Nguyen J, McMinn A, Selman C, Grobler AC, Daley A, Crawford NW. Stick with the nose...Saliva rapid antigen testing is not a viable method for testing children under 5 years old. J Paediatr Child Health. 2023 Feb;59(2):258-263. doi: 10.1111/jpc.16277. Epub 2022 Nov 18.
PubMed 36401338
Study at a glance
From the registry record, last updated by the sponsor on 8 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Diagnosis of Respiratory Viruses in Children With Rhinoswab Junior
- ClinicalTrials.gov ID
- NCT05043623
- Acronym / sponsor ID
- HREC/77305/RCHM-2021
- Conditions
- SARS CoV 2 Infection, COVID-19
- Keywords
- Rhinoswab Junior
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 339 participants (actual)
- Lead sponsor
- Murdoch Childrens Research InstituteUniversity, hospital or other
- Collaborators
- Rhinomed Pty Ltd
- Study start
- 26 Aug 2021 (actual)
- Primary completion
- 26 Jan 2022 (actual)
- Study completion
- 28 Aug 2022 (actual)
- First posted
- 14 Sep 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A study to investigate Rhinoswab as an alternative method to combined throat and deep nasal (CTDN) swab for respiratory sample collection in children who present to the Royal Children's Hospital (RCH) for viral testing. Children and their parent/guardian will answer a short survey about their preferences. Laboratory staff will answer a short survey about handling the different samples.
Detailed description
The microbiological test of choice for detection of respiratory viruses is a reverse transcription polymerase chain reaction (RT-PCR). The test is reported as "detected" or "not-detected" to the clinician. The Ct-value is a microbiological analysis that represents the number of amplification cycles required for a target gene to exceed a threshold level, to determine a negative or positive result and is interpreted to detect respiratory viruses. The Ct-value is used to measure viral load.
SARS-CoV-2, the virus that causes COVID-19, is a respiratory virus of specific interest. SARS-CoV-2 is detected in the upper respiratory tract. National guidelines for diagnosing COVID-19 in Australia require a combined throat and deep nasal swab (CTDN). No other testing options are routinely recommended in Australia. However, research and international guidelines recommend nasal swabs alone for SARS-CoV-2 detection. The Center for Disease Control and Prevention (USA) currently recommend the use of an anterior nasal swab alone as a method for detection of SARS-CoV-2. A recent systematic review suggested nasal swabs are a clinically acceptable alternative specimen collection methods. In addition to satisfactory diagnostic performance, nasal swabs are potentially less invasive, and can be self-collected.
Research at the Melbourne Children's Campus has identified that the CTDN or nasopharyngeal swab, are uncomfortable and distressing for children. The fear of the test is a barrier for presentation to a health service for a SARS-CoV-2 test. Parental and child reluctance to undergo testing may impact the public health response, through under-identification of pediatric cases.
The Rhinoswab is a TGA (Therapeutic Goods Administration) approved anterior nasal swab for children and adults. The design of the Rhinoswab allows for standardisation of the site of biological sampling, as compared with CTDN swabs which are operator dependent. It is designed to be more comfortable and to collect nasal secretions for PCR testing. The Rhinoswab Junior is a smaller paediatric version that has novelty features which add interest and distraction. The child can use the swab themselves, allowing autonomy and control. The capture and elution efficiency of the Rhinoswab has been shown to be comparable, if not slightly superior, to the capture and elution efficiency to the commercially available Copan eSwab by VIDRL (Victorian Infectious Diseases Reference Laboratory) and GNOMIX analyses.
The RCH has completed over 30,000 tests in children throughout the COVID-19 Pandemic from March 2020 to June 2021 at the Respiratory Infection Clinic and Emergency Department. The RCH nurses and doctors are well placed to trial the Rhinoswab due to extensive experience in testing children, and have developed related clinical practice guidelines.
This trial aims to determine the following in children 5-18 years of age:
- To determine the sensitivity and specificity of the Rhinoswab compared to the standard CTDN swab, in detecting viruses on the respiratory panel
- To determine whether Rhinoswab is non-inferior to the standard CTDN swab by comparing Ct values
- To determine the sensitivity and specificity of the throat swab alone and deep nasal swab alone, compared with the CTDN, in detecting respiratory viruses
- To investigate the comfort and preference of the Rhinoswab compared to the CTDN swab.
- To investigate the laboratory handling of the Rhinoswab compared to the CTDN swab.
- To determine the sensitivity and specificity of the Rhinoswab compared to CTDN swab, and saliva, in detecting respiratory viruses including SARS-CoV-2.
In children 1 month to 5 years:
- To investigate sensitivity and specificity of Rapid Antigen Test (RAT) compared to CTDN swab and saliva test in detected SARS-CoV-2
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 4
- Model description
- The study is organised sequentially into three phases due to research capacity Phase 1: The first 250 participants (5-18 years) will be randomly assigned to Arm 1 and Arm 2 for the clinician collected/supervised phase. Phase 2: 50 participants (5-18 years) will be allocated to Arm 3 for the self-collected Rhinoswab/saliva/combined nose+throat swab. Phase 3: 50 subsequent participants (1m - 5 years) will be allocated to Arm 4 for the self-collect throat+nose/saliva/RAT
| Arm | Type | Receives |
|---|---|---|
| Arm 1 - Clinician Collected/supervised Rhinoswab first, then CTDN swab | Experimental | Device: Rhinoswab Junior, Device: Combined nose and throat swabRhinoswab test administered and immediately followed by CTDN. Rhinoswab swab tested on respiratory panel vs CTDN swab tested on respiratory panel (standard of care). |
| Arm 2 - Clinician Collected/supervised CTDN swab first, then Rhinoswab | Experimental | Device: Rhinoswab Junior, Device: Combined nose and throat swabCTDN test administered and immediately followed by Rhinoswab. CTDN swab tested on respiratory panel (standard of care) vs Rhinoswab swab tested on respiratory panel. |
| Arm 3 - Self-collected Rhinoswab, saliva swab, CTDN | Experimental | Device: Rhinoswab Junior, Device: Combined nose and throat swab, Device: Saliva swabIn children 5-18 years, the child/parent/guardian collects the three samples, in order of patient/parent preference. All samples will be tested on the SARS-CoV-2 laboratory panel (Allplex™ SARS-CoV-2 Assay - Seegene Inc) |
| Arm 4 - Self-collected RAT, saliva, CTDN | Experimental | Device: Combined nose and throat swab, Device: Saliva swab, Diagnostic Test: Abbott Panbio™ COVID-19 antigen self-test kitIn children 1 month -5 years, the child/parent/guardian collects the three samples, in order of patient/parent preference. Saliva and CTDN samples will be tested on the SARS-CoV-2 laboratory panel (Allplex™ SARS-CoV-2 Assay - Seegene Inc), RAT test kit will be Abbott PanBio |
Who may qualify
- Ages
- 1 month to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- Symptomatic and requiring a COVID-19 test at RCH or confirmed/suspected COVID-19 at home.
- Aged between 1 month -18 years old.
- Parent/guardian present.
- Parents/self are able to provide consent.
Key exclusion criteria (3 listed)
- < 1 month or >18 years old.
- Recent head or neck surgery
- Inability (e.g. non-English speaking and if no interpreter is available) or unwillingness to consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Rhinoswab JuniorRhinoswab Junior is a single use self-administered nasal swab intended to collect clinical specimens from the patient's nasal passages | Device | Arm 1 - Clinician Collected/supervised Rhinoswab first, then CTDN swab, Arm 2 - Clinician Collected/supervised CTDN swab first, then Rhinoswab, Arm 3 - Self-collected Rhinoswab, saliva swab, CTDN |
| Combined nose and throat swabCombined nose and throat swab (standard of care) | Device | Arm 1 - Clinician Collected/supervised Rhinoswab first, then CTDN swab, Arm 2 - Clinician Collected/supervised CTDN swab first, then Rhinoswab, Arm 3 - Self-collected Rhinoswab, saliva swab, CTDN, Arm 4 - Self-collected RAT, saliva, CTDN |
| Saliva swabSaliva swab | Device | Arm 3 - Self-collected Rhinoswab, saliva swab, CTDN, Arm 4 - Self-collected RAT, saliva, CTDN |
| Abbott Panbio™ COVID-19 antigen self-test kitCOVID-19 antigen self-test kit for the screening of active COVID-19 infection. It is a single-use, in vitro, visually read rapid immunoassay that uses a human nasal swab specimen for the qualitative detection of nucleocapsid protein SARS-CoV-2 antigen. It is intended to be used manually by untrained lay users (self testing) in a private setting. | Diagnostic test | Arm 4 - Self-collected RAT, saliva, CTDN |
Primary outcome
Sensitivity of Rhinoswab compared with CTDN for 13 viruses on standard respiratory panel (Clinician collected/supervised)
Time frame: 5 minutes from administering test
The results (detected/not detected) on all 13 viruses on the standard respiratory panel from both the Rhinoswab and the standard swabs will be obtained, and the sensitivity of the Rhinoswab compared to the CTDN determined. Sensitivity is calculated only in the participants who tested positive for the respective virus using the CTDN swab and is calculated as the proportion patients who tested positive on the Rhinoswab among those who tested positive on the CTDN swab. 95% confidence intervals will be calculated.
Specificity of Rhinoswab compared with CTDN for 13 viruses on standard respiratory panel (Clinician collected/supervised)
Time frame: 5 minutes from administering test
The results (detected/not detected) on all 13 viruses on the standard respiratory panel from both the Rhinoswab and the standard swabs will be obtained, and the specificity of the Rhinoswab compared to the CTDN determined. Specificity is calculated only in participants who tested negative for respiratory viruses and is calculated as the proportion patients who tested negative on Rhinoswab among those who tested negative on CTDN swab. 95% confidence intervals will be calculated.
9 secondary outcomes
Ct-Value of respiratory viruses on Rhinoswab compared with Ct-value of respiratory viruses on CTDN (Clinician-Collected/Supervised)
Time frame: 5 minutes from administering test
Swab Preference Assessment (Clinician-Collected/Supervised )
Time frame: 5 minutes from administering test
Median Ct-value of SARS-CoV-2 on Rhinoswab vs saliva vs CTDN (Self-collected)
Time frame: 5 minutes from administering test
Sensitivity of Rhinoswab compared with CTDN for SARS-CoV-2 (Self-collected)
Time frame: 5 minutes from administering test
Specificity of Rhinoswab compared with CTDN for SARS-CoV-2 (Self-collected)
Time frame: 5 minutes from administering test
Comparison of RAT test (detected/not detected) to Ct-values for saliva and standard CTDN for SARS-CoV-2 only (Self-collected)
Time frame: 15 minutes from administering test
Sensitivity of RAT compared with saliva for SARS-CoV-2 only (Self-collected)
Time frame: 15 minutes from administering test
Sensitivity of RAT compared to standard CTDN for SARS-CoV-2 only (Self-collected)
Time frame: 15 minutes from administering test
Laboratory handling assessment
Time frame: 5 minutes for survey, to be completed up to 14 days post the last participant enrolled
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Feb 2023.
- Derived from this study: PubMed 37106344Tosif S, Lee LY, Nguyen J, Overmars I, Selman C, Grobler AC, McMinn A, Waller G, McNab S, Jarvis T, Steer A, Babl FE, Daley A, Crawford NW. A novel anterior nasal swab to detect respiratory viruses: a prospective study of diagnostic accuracy. BMC Pediatr. 2023 Apr 28;23(1):201. doi: 10.1186/s12887-023-03976-5.
- Derived from this study: PubMed 36401338Tosif S, Lee LY, Nguyen J, McMinn A, Selman C, Grobler AC, Daley A, Crawford NW. Stick with the nose...Saliva rapid antigen testing is not a viable method for testing children under 5 years old. J Paediatr Child Health. 2023 Feb;59(2):258-263. doi: 10.1111/jpc.16277. Epub 2022 Nov 18.
- Individual participant dataSharing planned: Yes. Beginning 12 months following analysis and article publication, the following will be made available long-term for use by future researchers from a recognised research institution whose proposed use of the data has been ethically reviewed and approved by an independent committee and who accept MCRI's conditions for access: • Individual participant data that underlie the results reported in this article after de-identification (text, tables, figures and appendices).
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Rhinoswab Junior, Combined nose and throat swab and Saliva swab in people with SARS CoV 2 Infection and COVID-19, run by Murdoch Childrens Research Institute at 1 site in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sensitivity of Rhinoswab compared with CTDN for 13 viruses on standard respiratory panel (Clinician collected/supervised) (time frame: 5 minutes from administering test). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05043623, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Feb 2023.